Family Influences to Prevent Childhood Obesity

Childhood Obesity Clinical Trial

— 4-Health  

Official title:

Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510587
• Other study ID #: 4W3685
• Secondary ID: 2009-55215-05334
• Status: Completed
• Phase: N/A
• First received: January 7, 2012
• Last updated: January 28, 2015
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.

Description:

Previous studies suggest that parents can play a key role in preventing childhood obesity. Program objectives are to increase parents' knowledge and skills related to nutrition, physical activity, and best parenting practices. Developed from a successful existing program, the proposed program will include a novel classroom curriculum coupled with outside exercises, online resources, and a strong social support network. The curriculum will be developed with input from stakeholders during year 1 and implemented during years 2 and 3. The target groups are children and parents participating in 4-H Youth Development Programs in Montana. Intervention effectiveness will be assessed by comparing objective and self-report data between-groups (intervention vs. control) and within-groups (pre- to post-intervention and at 6 month follow-up). Physiological measures, including resting heart rate, blood pressure, body weight and age- and gender-specific BMI z-scores of children, are expected to show significant improvement among children of parents receiving the intervention compared to a mailed written materials control group. In addition, positive changes are anticipated in outcome measures provided by parents and children, including levels of daily physical activity and specific food and nutrition behaviors. Positive changes in parents' attitudes about diet, body image, and their perceived feeding practices before versus after intervention and at 6 month follow-up are also expected. This project will lead to improved understanding of how parents influence child obesity and improved interventions to prevent obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parent of 8-12 year old child in 4-H Youth Development Programs in Montana

• Child of parent enrolled in study

Exclusion Criteria:

• Parent of child age outside the 8-12 year old range at start of trial

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 4-Health Educational curriculum
During the intervention, parents meet about every 3 weeks (90 min/session) in small groups with facilitators. During meetings classroom activities aim to integrate 3 areas: 1) parents' knowledge about healthy diets, physical activity and improved body image; 2) parents' understanding, skills and potential roles as positive change-agents (i.e., parenting and behavior management); and 3) parents' learning and practicing cognitive-behavioral exercises that encourage specific skills within the family/home setting. Between monthly meetings, participants explore a suggested online websites or facilitator-assigned questions and provide feedback. The majority of outside time/assignments for parents is spent doing take-home activities with their preteen child and family.
• Healthy Living Information
During the Healthy Living Information intervention, participants receive packets delivered to their homes by mail at intervals similar to the meeting intervals for the educational curriculum intervention. (10 total packets.) Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational Program, participants in the Healthy Living Information control group receive mailed packets of information.

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change child body mass index z-score.		Baseline, end of program, 6 month follow up	No
Secondary	Change in youth and parent self-reported physical activity.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child and parent physical activity self-efficacy.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child and parent dietary self-efficacy.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child and parent body image.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child quality of life via self-report and parent report.		Baseline, end of program, 6 month follow up	No
Secondary	Change in parent body mass index.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child and parent diastolic and systolic blood pressure.		Baseline, end of program, 6 month follow up	No
Secondary	Change in child and parent heart rate.		Baseline, end of program, 6 month follow up	No

External Links

•   Benke C, Bailey S, Eldridge G, Martz J, Paul L. 4-Health: A Programmatic Evaluation of a Parent-Based Childhood Obesity Prevention Program. Journal of Youth Development 8(3). 2013.
•   Benke CJ, Bailey SJ, Paul L, Lynch W, Eldridge G. Developing a Parent-Centered Obesity Prevention Program for 4-H Families: Implications for Extension Family Programming. Journal of Extension 51(3), 2013.